In Natural Alternatives Internat’l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. The claims at issue included method of treatment, product, and manufacturing claims. Here, I focus on the product claims. While the decision provides a welcome discussion of Chakrabarty and Funk Brothers, my enthusiasm is tempered by the narrow holding and Judge Reyna’s dissent.
In Ni-Q, LLC v. Prolacta Bioscience, Inc., the United States District Court for the District of Oregon invalidated under 35 USC § 101 Prolacta’s patent on testing milk to establish or confirm the identity of the donor. The decision was made on Ni-Q’s motion for summary judgement, and illustrates the reach of recent Federal Circuit jurisprudence on “diagnostic” methods.
In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast to Amerigen, where the court found standing for a would-be generic competitor whose ANDA was subject to a Paragraph III certification against the challenged patent, in Momenta the court found that the challenger’s termination of product development precluded standing.
In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, the Federal Circuit once again held diagnostic method claims invalid under 35 USC § 101. Footnote 4 of the majority decision blames the Supreme Court for this outcome, but Judge Newman’s dissent outlines her views on how the court could have followed all relevant Supreme Court precedent and reached a different conclusion by heeding Supreme Court guidance that patent claims must be considered as a whole.
The Federal Circuit decision in Mylan Pharmaceuticals, Inc. v. Research Corporation Technologies, Inc., highlights the difficulty of challenging a patent directed to a new chemical entity. The court affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that upheld the validity of RCT’s Vimpat lacosamide patent, which is approved for the treatment of epilepsy. The court considered the arguments that had been made for and against patentability under the “lead compound analysis” framework, and determined that the PTAB decision was supported by substantial evidence.